Letters Section Editor: Stephen J. Lurie,
MD, PhD, Senior Editor.
To the Editor: We have several concerns about
the Editorial by Drs DeAngelis and Fontanarosa1 regarding
the regulation of dietary supplements.
There is no substantiation of the claim by DeAngelis and Fontanarosa
that postmarketing regulation by the US Food and Drug Administration (FDA)
and the Federal Trade Commission (FTC) presents a "real danger" to the public.
Their assertion that the "onus is on FDA to demonstrate" a lack of safety
is only partially true. "New dietary ingredients" are marketed following approval
of safety files by the FDA. We believe that existing food ingredients and
supplements are safe based on years of uneventful human ingestion. Furthermore,
the Dietary Supplement Health and Education Act (DSHEA) grants the right to
take action if a supplement poses "an imminent hazard to public health" or
"presents a significant or unreasonable risk of illness or injury."
Joseph J, Kropp D, Madsen D, Yannicelli S. Regulation of Dietary Supplements. JAMA. 2004;291(5):560. doi:10.1001/jama.291.5.560-a